对于空腹血糖受损的中国患者，糖化血红蛋白（HbA1c）能否替代口服葡萄糖耐量试验（OGTT）用于糖尿病的诊断？
Can HbA1c replace OGTT for the diagnosis of diabetes mellitus among Chinese patients with impaired fasting glucose?
作者信息
Yu Esther Y T, Wong Carlos K H, Ho S Y, Wong Samuel Y S, Lam Cindy L K
机构信息
Department of Family Medicine and Primary Care, The University of Hong Kong, 3/F, Ap Lei Chau Clinic, No. 161 Main Street, Ap Lei Chau and
Department of Family Medicine and Primary Care, The University of Hong Kong, 3/F, Ap Lei Chau Clinic, No. 161 Main Street, Ap Lei Chau and.
出版信息
Fam Pract. 2015 Dec;32(6):631-8. doi: 10.1093/fampra/cmv077. Epub 2015 Oct 14.
BACKGROUND
HbA1c ≥ 6.5% has been recommended as a diagnostic criterion for the detection of diabetes mellitus (DM) since 2010 because of its convenience, stability and significant correlation with diabetic complications. Nevertheless, the accuracy of HbA1c compared to glucose-based diagnostic criteria varies among subjects of different ethnicity and risk profile.
OBJECTIVES
This study aimed to evaluate the accuracy of HbA1c for diagnosing DM compared to the diagnosis by oral glucose tolerance test (OGTT) and the optimal HbA1c level to diagnose DM in primary care Chinese patients with impaired fasting glucose (IFG).
METHODS
A cross-sectional study was carried out in three public primary care clinics in Hong Kong. About 1128 Chinese adults with IFG (i.e. FG level between 5.6 and 6.9 mmol/l in the past 18 months) were recruited to receive paired OGTT and HbA1c tests. Sensitivities and specificities of HbA1c at different threshold levels for predicting DM compared to the diagnosis by OGTT were evaluated. A receiver operating characteristic (ROC) curve was used to determine the optimal cut-off level.
RESULTS
Among the 1128 subjects (mean age 64.2±8.9 year, 48.8% male), 229 (20.3%) were diagnosed to have DM by OGTT. The sensitivity and specificity of HbA1c ≥6.5% were 33.2% and 93.5%, respectively, for predicting DM diagnosed by OGTT. The area under the ROC curve was 0.770, indicating HbA1c had fair discriminatory power. The optimal cut-off threshold of HbA1c was 6.3% for discriminating DM from non-DM, with sensitivity and specificity of 56.3% and 85.5%, respectively. HbA1c ≥ 5.6% has the highest sensitivity and negative predictive value of 96.1% and 94.5%, respectively.
CONCLUSIONS
HbA1c ≥ 6.5% is highly specific in identifying people with DM, but it may miss the majority (66.8%) of the DM cases. An HbA1c threshold of <5.6% is more appropriate to be used for the exclusion of DM. OGTT should be performed for the confirmation of DM among Chinese patients with IFG who have an HbA1c between 5.6% and 6.4%.
背景
自2010年以来，糖化血红蛋白（HbA1c）≥6.5% 因其便利性、稳定性以及与糖尿病并发症的显著相关性，被推荐作为糖尿病（DM）的诊断标准。然而，与基于血糖的诊断标准相比，HbA1c的准确性在不同种族和风险状况的受试者中存在差异。
目的
本研究旨在评估与口服葡萄糖耐量试验（OGTT）诊断相比，HbA1c诊断DM的准确性，以及在香港基层医疗中空腹血糖受损（IFG）的中国患者中诊断DM的最佳HbA1c水平。
方法
在香港的三家公立基层医疗诊所开展了一项横断面研究。招募了约1128名患有IFG的中国成年人（即过去18个月内空腹血糖水平在5.6至6.9 mmol/l之间），接受OGTT和HbA1c配对检测。评估了与OGTT诊断相比，不同阈值水平的HbA1c预测DM的敏感性和特异性。采用受试者工作特征（ROC）曲线确定最佳截断水平。
结果
在1128名受试者（平均年龄64.2±8.9岁，男性占48.8%）中，229人（20.3%）经OGTT诊断为DM。HbA1c≥6.5%预测经OGTT诊断的DM的敏感性和特异性分别为33.2%和93.5%。ROC曲线下面积为0.770，表明HbA1c具有一定的鉴别能力。区分DM与非DM的HbA1c最佳截断阈值为6.3%，敏感性和特异性分别为56.3%和85.5%。HbA1c≥5.6%具有最高的敏感性和阴性预测值，分别为96.1%和94.5%。
结论
HbA1c≥6.5%在识别DM患者方面具有高度特异性，但可能会遗漏大多数（66.8%）的DM病例。HbA1c阈值<5.6%更适合用于排除DM。对于HbA1c在5.6%至6.4%之间的中国IFG患者，应进行OGTT以确诊DM。
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